A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT (NCT04322318)

🧪 Interventions in This Study

• Carboplatin (DRUG)
• Cyclophosphamide (DRUG)
• Doxorubicin (DRUG)
• Etoposide (DRUG)
• Ifosfamide (DRUG)
• Irinotecan (DRUG)
• Topotecan (DRUG)
• Vincristine (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Patients with newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on APEC14B1, consented to Part A - Eligibility Screening, and have received an initial stratum assignment showing DAWT (if anaplasia first identified at diagnostic, pre-treatment nephrectomy or biopsy) or a final stratum assignment showing DAWT (if anaplasia first noted at delayed nephrectomy) prior to enrollment on AREN1921. Prior enrollment on APEC14B1 is not an eligibility requirement for patients with relapsed favorable histology Wilms tumor.
2. Patients must be =\< 30 years old at study enrollment
3. Patients with the following diagnoses are eligible for this study:
4. Newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor as confirmed by central review
5. Favorable histology Wilms tumor at first relapse. Relapsed FHWT patients must have previously achieved remission for their initial FHWT diagnosis to be eligible for this study. The relapse risk groups are defined as follows, regardless of radiation therapy:
6. Standard-Risk relapse: Patients who received two chemotherapy agents for frontline therapy; primarily actinomycin D and vincristine
7. High-Risk relapse: Patients who received three chemotherapy agents for frontline therapy; primarily vincristine, actinomycin D and doxorubicin or vincristine, actinomycin D and irinotecan
8. Very High-Risk relapse: Patients who received four or more chemotherapy agents as part of initial therapy; primarily regimen M or its variations
9. Patients with newly diagnosed DAWT must have had histologic verification of the malignancy. For relapsed FHWT patients, biopsy to prove recurrence is encouraged, but not required
10. Note: For relapsed FHWT patients, an institutional pathology report confirming favorable histology Wilms tumor (from relapse, if available, or from original diagnosis) must be available for upload prior to initiation of protocol therapy
11. Patients with newly diagnosed Stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on AREN1921 within 2 weeks of the tumor-directed surgery or biopsy procedure that first confirms a diagnosis of DAWT, whether at initial diagnostic procedure or delayed nephrectomy (such surgery/biopsy is day 0). For patients who received prior therapy for presumed favorable histology Wilms tumor, later confirmed to have diffuse anaplastic Wilms tumor at subsequent review of the initial biopsy
12. Patients with newly diagnosed DAWT who undergo upfront nephrectomy must have at least 1 lymph node sampled prior to study enrollment

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (205 Sites)

Showing the first 25 of 205 sites.

• Children's Hospital of Alabama — Birmingham, Alabama
• USA Health Strada Patient Care Center — Mobile, Alabama
• Providence Alaska Medical Center — Anchorage, Alaska
• Banner Children's at Desert — Mesa, Arizona
• Phoenix Childrens Hospital — Phoenix, Arizona
• Banner University Medical Center - Tucson — Tucson, Arizona
• Arkansas Children's Hospital — Little Rock, Arkansas
• Kaiser Permanente Downey Medical Center — Downey, California
• Loma Linda University Medical Center — Loma Linda, California
• Miller Children's and Women's Hospital Long Beach — Long Beach, California
• Children's Hospital Los Angeles — Los Angeles, California
• Cedars-Sinai Medical Center — Los Angeles, California
• Mattel Children's Hospital UCLA — Los Angeles, California
• Valley Children's Hospital — Madera, California
• UCSF Benioff Children's Hospital Oakland — Oakland, California
• Kaiser Permanente-Oakland — Oakland, California
• Children's Hospital of Orange County — Orange, California
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California
• University of California Davis Comprehensive Cancer Center — Sacramento, California
• Rady Children's Hospital - San Diego — San Diego, California
• UCSF Medical Center-Mission Bay — San Francisco, California
• Children's Hospital Colorado — Aurora, Colorado
• Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado
• Connecticut Children's Medical Center — Hartford, Connecticut
• Yale University — New Haven, Connecticut

📞 Contact the Study Coordinator

Phone: (205) 638-9285

Email: oncologyresearch@peds.uab.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Anaplastic Kidney Wilms Tumor clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.